FDA

A top U.S. health official on Thursday pledged to try to ban menthol from regular cigarettes, outlaw flavors in all cigars, and tighten rules regarding the sale of most flavored versions of electronic cigarettes.

Announcing the approval of a tablet alternative to a powerful opioid normally delivered intravenously, the commissioner of the Food and Drug Administration promised Friday that the drug Dsuvia will be very tightly regulated.

Keystone Laboratories has repeatedly failed to correct deficiencies cited by the FDA, including adulteration and misbranding of its over-the-counter drugs, the United States claims in a federal complaint.

Casting federal restrictions on e-cigarette advertising and sales as an existential threat, a trade group for the vaping industry urged the D.C. Circuit on Tuesday to block a rule change by the Food and Drug Administration.

GlaxoSmithKline cannot be held responsible for failing to warn older adults of the suicide risk attached to its antidepressant drug Paxil because the government refused to allow the drugmaker to add such a warning, the Seventh Circuit ruled.

Attorneys for a dietary supplement manufacturer asked the 11th Circuit on Friday to overturn a district court ruling which found that the U.S. government rightfully seized $2.2 million worth of a supplement ingredient.

Southern California resident Paula Kahn says she began exploring the use of psychoactive drugs as a teenager to help her heal from past trauma, a practice that health researchers – and health-tourism entrepreneurs – have begun studying and promoting in recent years.

The Seventh Circuit ruled that a dairy conglomerate cannot continue its $30 million advertising campaign saying its cheeses are safer than competitors’ products just because its cows do not consume a hormone supplement approved by the Food and Drug Administration.

A Ninth Circuit panel on Thursday entertained arguments over whether to reverse the dismissal of a lawsuit brought by a University of California researcher who claims the Food and Drug Administration’s failure to adequately regulate sleeping pills leads to thousands of deaths annually.

Ahead of a long weekend where millions will flock to beaches around the United States, conservationists petitioned the U.S. Food and Drug Administration on Wednesday to ban two chemicals found in sunscreen that are known to irreparably damage coral reefs.

The Food and Drug Administration is seeking a permanent injunction to stop two stem cell clinics from treating patients with stem cell products for serious health conditions and diseases, claiming that the treatments were marketed without proof of safety from the FDA, according to complaints filed Wednesday in federal court.

U.S. health officials are placing new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant called Essure will remain on the market.

A class claims in a federal complaint that Akorn Inc.’s executives did not disclose that the pharmaceutical company’s noncompliance with federal data integrity requirements would jeopardize its acquisition by a health care firm, causing share prices to drop 38 percent to $18.65.

A coalition of environmental, food safety and animal rights groups dropped their legal challenge over the U.S. Food and Drug Administration’s approval of an animal-growth drug that is banned in dozens of nations.

Injected with 600 million stem cells grown from his own stomach fat, an elderly man said the injections stopped his Parkinson’s disease tremors and he’s now teeing up his own golf balls and competing in golf tournaments.

Shareholders of biopharmaceutical company Tesaro Inc. claim in a class action that the company covered up health risks associated with a cancer drug until forced by the U.S. Food and Drug Administration to report the drug’s serious adverse effects.